A Third of Independent Pharmacies May Close

By Pat Anson, PNN Editor

These are tough times for many retail pharmacies and their customers. Big chain pharmacies like CVS, Walgreens and Rite Aid are closing over 1,500 stores, as they grapple with declining sales, higher debt, drug shortages, fallout from opioid litigation, and an overworked, demoralized workforce.

For many patients who had trouble getting their prescriptions filled for opioids and other controlled substances, small independent pharmacies became a welcome refuge from the big chains.

“I'm fortunate to have a compassionate, independent pharmacy that bends over backwards to ensure I have the meds my doctor prescribes. If I was stuck with a chain pharmacy like Walgreens or CVS, my experience would be completely different. Those pharmacies treat pain patients like criminals,” one patient told us.

But now even the independent pharmacies are threatened. About a third of them could close in 2024, according to a dire prediction from the National Community Pharmacists Association (NCPA), a trade group that represents nearly 20,000 independent pharmacy owners in the U.S.

“Nearly a third of independent pharmacy owners may close their stores this year under pressure from plunging prescription reimbursements by big insurance plans and their pharmacy benefit managers,” says B. Douglas Hoey, RPh, NCPA’s CEO.

At issue is a new rule by the Centers for Medicare & Medicaid Services (CMS) that requires insurers and pharmacy benefit managers (PBMs) to implement discounts and price concessions at the point of sale, where a drug is dispensed. The rule is intended to make pricing more transparent for patients, but it’s hurting the bottom line of pharmacies who say the discounts are being unfairly forced on them by insurers.

Part D Prescriptions at Risk

In a recent survey of NCPA members, 32% said they may have to close by the end of the year due to the CMS rule and 93% said they’d consider dropping out of Medicare’s Part D prescription drug program. Most say they are losing money on Part D prescriptions, which don’t compensate the pharmacies for rent, taxes, payroll and other costs of doing business.

“Cash flow for many pharmacies remains in a precarious state, leading to dire concerns for beneficiary access. Our members continue to experience significant harm from egregious Medicare Part D PBM practices,” Hoey wrote in a letter to CMS, which faulted the agency for doing little to stop the PBMs.

Asked which PBMs are causing the most financial stress in the Part D program, almost half the NCPA members identified Express Scripts, with CVS/Caremark coming in at 35 percent.

Hoey says CMS already has the legal authority to change reimbursement practices, but wants Congress to intervene if CMS doesn’t act soon.

“This is an emergency. And if Congress fails to act again, thousands of local pharmacies could be closed within months and millions of patients could be stranded without a pharmacy,” Hoey said in a statement.

NCPA says there are about 2,200 fewer retail pharmacies today than there were four years ago. This has created hundreds of pharmacy “deserts,” primarily in low-income rural and urban areas, where access to a pharmacy is limited or non-existent. Alabama alone has lost 300 pharmacies in recent years.

“With every closure, 5,000 Alabamians are left without a critically important health care provider. This is a major issue for every community in our state, but rural Alabama is hit the hardest. In many cases, that local pharmacy is the only healthcare provider in that rural community,” Alabama State Rep. Phillip Rigsby, a pharmacist, wrote in an op/ed published in AL.com.

“In other businesses, if an operating cost increases, the company’s prices increase to compensate. In pharmacy, that just is not possible. A pharmacy cannot pass on that cost to a patient because the contract doesn’t allow for that.”

GAO Seeks Expanded Tracking of Medicare Rx Opioids

By Pat Anson, Editor

A new report to Congress by the Government Accountability Office (GAO) recommends that the federal government greatly expand the monitoring of Medicare patients who receive high doses of opioid pain medication, as well as the doctors who write their prescriptions.

If adopted, an estimated 727,000 Medicare beneficiaries who receive opioids in excess of 90mg morphine equivalent doses (MED) would have their prescriptions tracked by private insurers and reported to the Centers for Medicare & Medicaid Services (CMS). Critics say such a policy would have a chilling effect on doctors, who increasingly fear government sanctions for prescribing opioids.

In 2016, over 14 million elderly and disabled Medicare patients received an opioid prescription, and CMS spent over $4 billion paying for their opioid medication.

“A large number of Medicare Part D beneficiaries use prescription opioids, and reducing the inappropriate prescribing of these drugs is a key part of CMS’s strategy to decrease the risk of opioid use disorder, overdoses, and deaths,” the GAO report says.

“Despite working to identify and decrease egregious opioid use behavior — such as doctor shopping — among beneficiaries in Medicare Part D, CMS lacks the necessary information to effectively determine the full number of beneficiaries at risk of opioid harm.”

Under current CMS policy, patients are only considered “at risk” if they receive high dose opioid prescriptions from four or more providers and have them filled at four or more pharmacies. Last year, 11,594 Medicare beneficiaries met that criteria, a tiny fraction of those who receive opioids.

The GAO wants to change the criteria so that everyone prescribed a high dose would be monitored, regardless of how many doctors or pharmacies they use.  The principal author of the report said the recommendation is not aimed at taking patients off opioids or lowering their dose, but to improve the data on high dose prescribing.

“We are suggesting that CMS take a close look and monitor and track the numbers of people at risk of harm,” Elizabeth Curda, Director of GAO Health Care, told PNN. “We’re not suggesting CMS investigate 700,000 people who get more than 90mg per day. We want them to focus on how many people are getting these doses and what’s happening to that number. Is it going down? Is it going up?  We have this strategy to reduce harm, so we want to see it coming down.”

“Frankly this is unbelievable.  It is very hard for me to understand how reducing the amount of opioids to people in pain is going to help reduce the amount of smuggled heroin and fentanyl into the United States,” says Lynn Webster, MD, a pain management expert and past president of the American Academy of Pain Medicine.  “We need to remember 3 out of 4 drug overdoses do not involve a prescription opioid.  And most of the overdose deaths involving prescription opioids are not in people prescribed the medications.”

Webster is also concerned about a GAO recommendation that Medicare insurers be required to identify and report to CMS all high-dose opioid prescribers. Currently, there’s only a voluntary reporting system when doctors are investigated for fraud, waste or abuse.

“Investigating doctors who prescribe high dose opioids will have a chilling effect.  It will deter all providers from treating people with pain at any dose.  People will suffer.  There will be more suicides because of inadequately treated pain. This is not hyperbole,” said Webster. 

“The whole notion that reducing dose will solve the opioid crisis is misguided.  People who benefit from the high doses will be denied pain relief and those who use any dose for non-medical purposes will just seek illicit and more lethal drugs.”

Patients and Prescribers Ignored

Critics of the GAO report are also disturbed that the agency did not consult with any pain sufferers, patient advocacy organizations or professional medical organizations that represent prescribers. Instead, the GAO met primarily with insurance companies, regulators and addiction treatment specialists.

"We interviewed officials from the largest six health care plan sponsors: Aetna, Cigna, CVS Health, Express Scripts, Humana, and United Health Group," the GAO report says in a footnote.

"We also interviewed 12 stakeholders that represent a range of perspectives on opioid use and prescribing patterns in Medicare: AARP, American Health Insurance Plans, American Society of Interventional Pain Physicians, Brandeis Prescription Drug Monitoring Program Training and Technical Assistance Center, Federation of State Medical Boards, National Association of Drug Diversion Investigators, National Association of Medicaid Directors, National Healthcare Antifraud Association, Pew Charitable Trust, Pharmaceutical Care Management Association, Physicians for Responsible Opioid Prescribing (PROP), and one expert on opioid abuse."

The GAO would not identify any of the individuals it met with, saying the interviews were conducted on a “not for attribution” basis to encourage frank discussion. However, it seems likely that Andrew Kolodny, MD, was interviewed, as he is the founder and Executive Director of PROP, works at Brandeis University, and is considered by some to be an expert on opioid abuse.

Kolodny, who is the former chief medical officer of the addiction treatment chain Phoenix House, did not respond to a request for comment. Pain News Network is filing a request under the Freedom of Information Act with the GAO to disclose who they talked to.

ANDREW KOLODNY, MD

“I find it very disturbing that federal agencies continue to ignore pain care providers and advocacy groups for people with pain when they formulate policies that very clearly will impact those parties. Again and again, they consult with parties that have a vested interest in reducing opioid prescribing regardless of the impact on people with pain," said Bob Twillman, PhD, Executive Director of the Academy of Integrative Pain Management.

“They even go so far as to invite one solo participant who is an ‘expert on opioid abuse.’ It’s as if they were asking representatives from the sugar industry to help develop guidelines on when artificial sweeteners should be used. Clearly, this speaks to a policy that is concerned with driving down opioid prescribing across the board, without considering the needs of the people with pain who actually benefit from opioid analgesics. It’s wrong, and everyone with a stake in pain management should demand that they start allowing us to sit at the table, rather than just to be on the menu.”

“It appears the GAO did not include patients, professional pain organizations and the American Medical Association in their deliberations. I would like to know how they feel their process can be justified,” added Webster. “They only invited groups to comment that appear to benefit financially from reduced prescribing or are opposed philosophically to opioids for non-cancer pain treatment.”

The only professional medical organization the GAO did consult with, the American Society of Interventional Pain Physicians, represents doctors who typically specialize in spinal injections and surgery.

The GAO’s Elizabeth Curda downplayed the role of people who were interviewed, telling PNN they were “not a major part of our methodology” in preparing the report.

Pain patients and pain management experts are often excluded or ignored when federal decisions are made about pain care.

The Centers for Disease Control and Prevention failed to consult with patients or practicing pain physicians while drafting its 2016 opioid prescribing guideline and secretly holding many of its deliberations.  The CDC also ignored a warning from its own consultant that some doctors stopped prescribing opioids after the guideline was issued.

Patients and doctors were also excluded from a closed door meeting of the Healthcare Fraud Prevention Partnership -- an obscure federal advisory group – when it met in "special session" last year to discuss Medicare's opioid prescribing policies. As PNN reported, major insurers like Aetna, Anthem, Cigna and Humana were invited to attend, but no other stakeholders in pain care were asked to appear or to share their insights.

More recently, President Trump’s opioid commission released its final report without taking any public testimony from pain sufferers, patient advocates or pain management physicians.

Law Firm Wants Transparency in Medicare Opioid Policy

By Pat Anson, Editor

A Washington-based legal firm is calling for more openness and transparency by the Centers for Medicare and Medicaid Services (CMS) as it establishes new rules that are likely to limit access to opioid pain medication for millions of Medicare patients.

“While opioid abuse undoubtedly presents a serious public health issue, CMS should take steps to foster transparency and avoid harming patients and providers alike by offering them a meaningful opportunity to participate in the development of policies that could limit pain management,” wrote Michelle Stilwell, a staff attorney for the Washington Legal Foundation (WLF), a non-profit law firm that generally supports business groups and companies in litigation against government agencies.

At issue are mandatory rules being developed by CMS for 2018 that would bring Medicare opioid policies into alignment with the “voluntary” prescribing guidelines released last year by the Centers for Disease Control and Prevention.

CMS wants to set a daily ceiling on opioid pain medication at 90mg morphine equivalent dose (MED). If a dose exceeds that level, Medicare insurers would be expected to impose a "soft edit" that would automatically block the prescription from being filled until the edit is overridden by a pharmacist.

Stilwell wrote on the WLF's blog that patients and providers were given little opportunity to see and comment on a Call Letter announcing the rule changes, while the insurance industry was.

“CMS’s changes will inevitably lead to even tighter restrictions on opioid prescriptions—which directly affects the patient community.  Many patients, doctors, and healthcare providers already complain that rules designed to prevent the improper prescribing of opioids are complicating patients’ legitimate access to appropriate medication,” said Stilwell. 

“But instead of directing this Call Letter at the affected patient community and granting that community an adequate opportunity to comment on the new opioid overutilization criteria, CMS directed it only to insurance companies.  In reality, opioid consumers and providers are given little to no notice or opportunity to comment."

As PNN has reported, the insurance industry appears to have played a major role in drafting the CMS rules, which contains some of the same strategies suggested in a “white paper” prepared by the Healthcare Fraud Prevention Partnership (HFPP), a coalition of insurers, law enforcement agencies and government regulators formed to combat insurance fraud. The HFFP met to discuss the white paper in a “special session” last October that was not open to the public.

Stilwell said the HFFP “operates largely in the dark” and may be in violation of the Federal Advisory Committee Act (FACA), which requires open meetings for all federal advisory panels. This week the WLF filed a Freedom of Information Act Request seeking more information about HFPP membership and meetings.

Major insurers such as Aetna, Anthem, Blue Cross Blue Shield, Cigna, Highmark, Humana, Kaiser Permanente and the Centene Corporation participate in the HFPP.

“It is time for CMS to bring HFPP into compliance with FACA requirements.  Doing so will reduce the risk that a court may invalidate any CMS policies found to have been adopted at least in part in reliance on HFPP recommendations.  It would also enable any patients affected by changes in opioid reimbursement policies to play a role in the development of HFPP’s opioid-related recommendations,” Stilwell wrote.

CMS contracts with dozens of insurance companies to provide health coverage to about 54 million Americans through Medicare and nearly 70 million in Medicaid. CMS policies often have a sweeping impact throughout the U.S. healthcare system because so many insurers and patients are involved.

In addition to limits on opioid prescribing, CMS plans to implement an opioid Overutilization Monitoring System (OMS) to identify physicians who regularly prescribe high doses of opioids. Patients who receive opioids from more than 3 prescribers and more than 3 pharmacies during a 6 month period would also be red-flagged. Insurers would be required to identify pharmacies, doctors and patients who do not follow CMS policies, and could potentially drop them from Medicare coverage and their insurance networks.

FDA to 'Take Whatever Steps We Can’ to Stop Opioid Abuse

Meanwhile, the new commissioner of the Food and Drug Administration is calling on the agency to “take whatever steps we can” to ensure that opioids are only prescribed under “appropriate clinical circumstances.”

In a blog post on the FDA website, Scott Gottlieb, MD, announced the formation of an Opioid Policy Steering Committee to develop additional tools and strategies the FDA can use to prevent opioid abuse.

“Patients must be prescribed opioids only for durations of treatment that closely match their clinical circumstances and that don’t expose them unnecessarily to prolonged use, which increases the risk of opioid addiction,” he wrote.

Gottlieb wants the committee to focus on three areas:

scott gottlieb, MD

• Consider mandatory education for health care professionals about opioid prescribing recommendations and how to identify patients at risk of abuse.
• Establish limits on the dose and quantity of opioid medication that are more closely tailored to the medical condition a patient is being treated for.
• Review the process the FDA uses to evaluate and approve new opioid medications.

Gottlieb cited some questionable statistics to dramatize the extent of the opioid prescription problem.

“In 2015, opioids were involved in the deaths of 33,091 people in the United States. Most of these deaths – more than 22,000 (about 62 people per day) – involved prescription opioids,” he wrote.

The new FDA commissioner may want to check his facts. As PNN has reported, a news release last December from the White House Office of National Drug Control Policy stated that 17,536 Americans died in 2015 from overdoses involving prescription opioids.

A CDC news release a few days later provided an an even lower estimate; that over 12,700 Americans died from pain medications in 2015.

When asked to explain the discrepancy, PNN was given a third estimate by the CDC, which put the number of deaths involving prescription opioids at 15,281 in 2015.

Gootlieb's post links to a CDC website that provides a fourth estimate, which is based on a "standard analysis approach" that combines all overdoses caused by natural, semi-synthetic, and synthetic opioids. Such an approach is misleading, because it counts overdoses caused by illicit fentanyl as prescription drug deaths. 

"Unfortunately, information reported about overdose deaths does not distinguish pharmaceutical fentanyl from illegally-made fentanyl," the CDC said, which Gottlieb neglected to mention in his blog post.

Medicare Modifies Opioid Prescribing Plan

By Pat Anson, Editor

The Centers for Medicare and Medicaid Services (CMS) is moving ahead with plans to align its Medicare Advantage and Part D prescription drug plans with the CDC’s opioid prescribing guidelines.

However, the agency has modified a policy to ensure that high doses of opioids that are medically necessary can still be prescribed.

Like the CDC guideline, CMS is recommending a daily ceiling on opioid pain medication at 90 mgs of a morphine equivalent dose (MED).  If a dose exceeds that level, Medicare insurers are expected to impose a "soft edit" that would automatically block the prescription from being filled until the edit is overridden by a pharmacist. 

Under a previous proposal, insurance companies could also impose a “hard edit” that could not be overridden on prescriptions that exceed 200 mgs of MED. The modification allows a pharmacist to override the edit if the prescribing physician says the dose is medically needed.

“Point of sale edits are not intended to substitute physician judgment or dictate a prescribing limit. If a sponsor (insurer) chooses to implement a hard edit, CMS expects the sponsor to rely only on prescriber attestation that the MED is medically necessary to override the hard edit, and to not require additional clinical criteria,” a senior CMS official said in a news briefing.

“The edits are not to stop prescriptions. They’re to provide information to sponsors in real time as a preventative step, so that prescribers are aware of the amount of opioids that patients are receiving as well as that they may be receiving opioids from other doctors.  They are not prescriber limits and they are not to substitute for prescriber judgement.”

CMS said there was a “significant number of comments” from the public about its opioid prescribing proposal. Some doctors and patient advocacy groups expressed concern that pain patients who are medically stable on high opioids doses would be forced to taper to lower doses.

“My tentative judgement, based on quickly looking at the documents today, is that CMS carefully stepped back from the absolute requirement that would have caused patients at over 200 (MED) mgs to have a sudden crisis in their care,” said Stefan Kertesz, MD, a practicing physician and Associate Professor at the University of Alabama at Birmingham School of Medicine.

“That doesn’t mean that they have foresworn this course of action in the future, but they clearly registered that they heard concerns from patients, doctors and others, and to me that is a hopeful sign.”

CMS is still moving ahead with plans to implement an opioid Overutilization Monitoring System (OMS) to identify physicians who prescribe high doses and the patients who receive them. Patients who receive opioids from more than 3 prescribers and more than 3 pharmacies during a 6 month period would also be red-flagged.

Insurers are expected to identify pharmacies, doctors and patients who do not follow CMS policies, and could potentially drop them from Medicare coverage and their insurance networks.

As PNN has reported, the insurance industry appears to have played a major role in drafting the OMS plan, which contains some of the same strategies suggested in a “white paper” prepared by the Healthcare Fraud Prevention Partnership, a coalition of insurers, law enforcement agencies, and federal and state regulators formed in 2013 to combat healthcare fraud. 

The white paper goes far beyond fraud prevention, however, by recommending policies that will determine how a patient is treated by their doctor, including what medications should be prescribed.  The white paper was drafted largely by insurance companies, including Aetna, Anthem, Blue Cross Blue Shield, Cigna, Highmark, Humana, Kaiser Permanente and the Centene Corporation.

CMS contracts with dozens of insurance companies to provide health coverage to about 54 million Americans through Medicare and nearly 70 million in Medicaid. CMS policy changes often have a sweeping impact throughout the U.S. healthcare system because so many insurers and patients are involved.

A Letter to Medicare From a Worried Pain Patient

Editor’s Note: This Friday marks the deadline for the public to comment on opioid prescribing guidelines proposed by the Centers for Medicare and Medicaid Services (CMS). As PNN has reported (see “Medicare Planning to Adopt CDC Opioid Guidelines”), the guidelines are likely to limit access to opioid pain medication for millions of Medicare beneficiaries. They would also empower insurance companies to take punitive action against pharmacies, doctors and patients that don’t follow the guidelines.

The following is a letter written in opposition to the CMS guidelines by Ms. Judith Botamer. She has graciously agreed to let us publish it here in the interest of getting more people to send their own comments to CMS. 

All comments should be emailed to CMS no later than March 3 to this address:

AdvanceNotice2018@cms.hhs.gov

To Whom It May Concern:

As a disabled chronic pain patient, I strongly oppose the Centers for Medicare and Medicaid Services’ plan to accept policies from the recent CDC Guideline for Prescribing Opioids for Chronic Pain. I implore you to take action so that this mandate does not become a reality for the 100 million Americans who suffer with chronic pain, including many on Medicare.

The CDC guideline is simply a voluntary guide intended for primary care physicians only. The CMS guideline as written gives no margin or credence to pain management doctors who already have strict opioid policies, as well as an established ongoing relationship with their patients.

Your currently drafted policy makes the guidelines mandatory for all doctors, patients and pharmacists, and imposes a ceiling on the highest dose of opioids that can be prescribed. This gives physicians no discretion in determining what is right for their patients. That was never the CDC’s intent, nor is it feasible to expect all chronic pain patients to be able to maintain the level of care that their doctor has established for them.

I am permanently disabled with neuropathy, RA, fibromyalgia, torn disks, TMJD and migraines, as well as many other pain conditions for which there is no cure. At the young age of 53, I sometimes feel my life is over. If not for pain control from opioid medication, it surely would become a reality.

I never asked to be overcome with this much pain from so many “invisible illnesses.”  As a prior athlete, I am challenged daily to accept the reduced quality of life for myself and, in turn, for my family. Fortunately, my empathetic pain doctor will prescribe me enough medication so that I am functioning. If my current regimen were to be lowered to the amount set forth in this guideline, I would not be able to fully care for myself, perhaps be bedridden, and be left with a dramatically diminished quality of life.

This mandate actually takes away my right to a quality of life that I deserve. The burden of being struck with legitimate pain conditions should not equate to the loss of a right to live life with dignity, just as any other patient with any other chronic illness.

Many doctors are now frightened of prescribing pain medication for fear the CDC, DEA or FDA would sanction their license, when they simply want to fulfill their oath of “do no harm.” And let's be clear, not prescribing pain medication to a patient who is suffering, is doing harm! Not only for the patient, but for our communities and society as a whole.

To this point, on June 1, 2016, Dr. Debra Houry, the director of the CDC’s National Center for Injury Prevention and Control, wrote the following:

“The Guideline is a set of voluntary recommendations intended to guide primary care providers as they work in consultation with their patients to address chronic pain. Specifically, the Guideline includes a recommendation to try taper or reduce dosage only when patient harm outweighs patient benefit of opioid therapy. The Guideline is not a rule, regulation, or law. It is not intended to deny access to opioid pain medication as an option for pain management. It is not intended to take away physician discretion and decision-making.”
  

I truly hope that there is no collusion between the insurance industry and CMS in drafting your new “Opioid Misuse Strategy.” Taking pain medication away from a pain patient will not stop the criminals, drug cartels or addicts. Those issues are worlds away. Pain patients are not addicts or looking for a “high.” They depend on their medication just as a diabetic depends on insulin for life quality.

Please join me and become an empathetic advocate for the millions who suffer in silence as a result of just a few who break the law and displace attention away from the real tragedy: Pain patients being denied medical treatment, being treated as criminals, and their doctors being threatened for only doing the right thing!

For all of these reasons and more, CMS should not adopt or align your agency’s policies with the CDC Guideline, as it is apparent you have misinterpreted them.

Sincerely,
Judith A. Botamer

Pain News Network invites other readers to share their stories with us.

Send them to: editor@PainNewsNetwork.org. 

The information in this column should not be considered as professional medical advice, diagnosis or treatment. It is for informational purposes only and represents the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.

The Magical Opioid Number

By Roger Chriss, Guest Columnist

Numbers can be impressive. They seem like powerful evidence or useful metrics in regulations and legislation.

In 2016, the Centers for Disease Control and Prevention issued its guidelines for opioid prescribing, setting a recommended daily limit on opioid doses at 90 morphine milligram equivalent (MME). Now the Centers for Medicare and Medicaid Services (CMS) is on the cusp of adopting that number as a requirement for Medicare recipients. Physicians around the country have already started using it and so has the Veterans Administration.

In addition, Maine has passed a state law with a maximum 100 MME allowed for opioid prescribing starting on July 1, 2017. New Jersey, Virginia and other states are also passing laws restricting opioid prescribing by dose or duration, often citing the CDC guidelines as justification. 

But this number is all but arbitrary. The CDC guidelines recognize that the 90 MME ceiling was based on limited evidence. Obviously, patients are not safe at either 80 MME or doomed at 100 MME.

Nor can this number be used to calculate the safe number of days or doses for an opioid prescription. It is a magical number. And magical numbers can lead to magical thinking.

In fact, the 90 MME from the CDC cannot even be reliably calculated. The CDC offers an app that allows physicians to calculate the 90 MME. Its basic methodology is described here. Web sites like Practical Pain Management also offer an opioid calculator, and third-party developers have created opioid conversion apps.

But it turns out that the results of these calculators are inconsistent. Dr. Jeffery Fudin and his students have shown that the various methods of calculating MME produce significantly different outcomes.

Thus, how much of a morphine equivalent dose an individual is actually allowed to receive depends on which method is used. This uncertainty makes the 90 MME level clinically less than meaningful and potentially dangerous.

Existing research does show an increased risk of addiction and overdose as the daily dose of an opioid medication rises. But this is exactly what we should see. Most substances are more dangerous in larger quantities, after all. But each patient is different: gender, age, health status, prior opioid exposure, and other factors all play a significant role in determining a safe and effective dose of an opioid medication.

A cutoff like 90 MME is at best arbitrary. At worst it leaves some patients undertreated, and may harm patients who are forced to taper to the 90 MME threshold from a higher dose that has been safe and effective for them.

In addition, it is not entirely clear how the magic number of 90 MME was determined. The CDC developed its guidelines in a largely closed-door process that involved outside consultants whose identity was not revealed at the time. Most magical numbers are like this: their justification is thin and often obscured.

Meanwhile, the CMS and states like New Jersey and Maine are ignoring more important numbers. A recent STAT News article reported that opioid prescriptions have been falling since 2012 and that the misuse of pain relievers bottomed out in 2014. In other words, opioid prescribing is no longer a driving factor in the opioid crisis -- street drugs are.

The magical number of 90 MME is simply not justified. The relative risk of prescription opioids, in particular for people with chronic or intractable pain, is quite low. This fact was ignored in the CDC guidelines and in state government regulation. But it should be obvious: Most Americans have taken opioids at some point in their lives, whether after trauma or surgery or as a part of dental care. And it is abundantly clear that the majority have not become addicted to opioids. Again, the magic number is not real.

On February 9, 1950, Senator Joe McCarthy gave a speech in Wheeling, West Virginia, claiming that the U.S. State Department was infested with Communists, specifically 205 of them. This number helped launch a wave of political repression, fear-mongering, and social paranoia that we now refer to as McCarthyism. Nothing good came of that era, except maybe a cautionary note about how magical numbers can contribute to tragic results.

We are facing a similar risk with opioids, a magical number motivated by magical thinking by regulators and policymakers -- none of which is likely to help address the opioid crisis or the tragedy of addiction.

Instead, millions of people who may benefit from short-term opioid therapy after trauma or surgery will be denied effective medication for pain management, and tens of thousands of people with chronic conditions for whom opioid therapy is a critical component in maintaining a reasonable quality of life will be harmed. These are real numbers that we really need to pain attention to.

Roger Chriss suffers from Ehlers Danlos syndrome. Roger is from Washington state, where he works as a technical consultant who specializes in mathematics and research.

Pain News Network invites other readers to share their stories with us.  Send them to:  editor@PainNewsNetwork.org. 

The information in this column should not be considered as professional medical advice, diagnosis or treatment. It is for informational purposes only and represents the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.

How We Can Stop Medicare’s ‘Big Brother’ Opioid Policy

By Rick Martin, Guest Columnist

How many readers who leave comments on PNN are doing more than just commenting?

Change takes work if the pain community is going to stop the Centers for Medicare and Medicaid Services (CMS) from making the CDC’s opioid prescribing guidelines mandatory for millions of Medicare patients, including a ban on daily doses higher than 90 mg morphine equivalent (see “Medicare Planning to Adopt CDC Opioid Guidelines”).

We don’t need CMS and the insurance industry dictating what medication a physician can prescribe for pain or the appropriate amount of medication needed (see "Insurers Behind Medicare's 'Big Brother' Opioid Policy").

In my opinion, this is what needs to be done:

We have to start a chain letter.

I propose a form letter that everyone can copy and paste, forward, fax and mail to friends, family, caregivers, bloggers, Facebook, Twitter, and any other viable means of communication.  

You have to send it to at least 10 people. And ask them to send it to 10 people they know.

The letter also needs to be sent to patient advocacy groups like the U.S. Pain Foundation, American Chronic Pain Association, International Pain Foundation and the Alliance for Balanced Pain Management, a coalition of advocacy groups. They can post it in their newsletters and alert their members to what CMS is doing. This is the only way to reach a huge amount of people in a short amount of time. 

Here are their email addresses:

• U.S. Pain Foundation:  contact@uspainfoundation.org 
• American Chronic Pain Association:  acpa@theacpa.org 
• International Pain Foundation:  info@internationalpain.org 
• Alliance for Balanced Pain Management:  info@alliancebpm.org

We need to rein in CMS from dictating how we should live and the ability of our physicians to treat us. It won’t be easy. It took me 27 letters to the CDC to get a response from Dr. Debra Houry, who helped draft the agency’s guidelines.  

CMS is only accepting emailed public comments to their proposal until March 3, 2017. They will publish the final rules on April 3, so there is not much time. We must all act NOW.

Here is what I am emailing to CMS at this email address: AdvanceNotice2018@cms.hhs.gov

To Whom It May Concern:

I oppose the Centers for Medicare and Medicaid Services’ plan to align its policies with the CDC Guideline for Prescribing Opioids for Chronic Pain.

The CDC guideline is voluntary and gives physicians discretion in determining what is right for their patients. However, your policy as presently drafted will make the guidelines mandatory for all doctors, patients and pharmacists, and impose a ceiling on the highest dose of opioids that can be prescribed. That was never the CDC’s intent. 

On June 1, 2016, Dr. Debra Houry, Director of the CDC’s National Center for Injury Prevention
and Control, wrote the following:

“The Guideline is a set of voluntary recommendations intended to guide primary care providers as they work in consultation with their patients to address chronic pain. Specifically, the Guideline includes a recommendation to taper or reduce dosage only when patient harm outweighs patient benefit of opioid therapy. The Guideline is not a rule, regulation, or law. It is not intended to deny access to opioid pain medication as an option for pain management. It is not intended to take away physician discretion and decision-making.”

The following are additional quotes from the CDC Guideline itself:

"Clinicians should consider the circumstances and unique needs of each patient when providing
care.”

"Clinical decision making should be based on a relationship between the clinician and patient,
and an understanding of the patient's clinical situation, functioning, and life context."

"The Guideline provides recommendations for primary care providers who are prescribing opioids for chronic pain outside of active cancer treatment, palliative care and end-of-life-care."

Your policy does not provide an exception for palliative care, only patients receiving cancer treatment or end-of-life care. In my opinion, that is a blatant omission.

The facts are also available showing there has been collusion between the insurance industry and CMS in drafting your new “Opioid Misuse Strategy.”

For all of these reasons and more, CMS should not adopt or align your agency’s policies with the CDC Guideline, as it is apparent you have misinterpreted them.

Sincerely,

Rick Martin

Feel free to copy my letter or make changes to express your own views. It also might be helpful to attach a copy of Dr. Houry’s letter in your email. If anyone wants a copy of her letter, click here to download it.

Time is running out if we want to put a stop to this.

Rick Martin is a retired pharmacist in Nevada who was disabled by chronic back pain.

Pain News Network invites other readers to share their opinions and stories with us.  Send them to:  editor@PainNewsNetwork.org. 

The information in this column should not be considered as professional medical advice, diagnosis or treatment. It is for informational purposes only and represents the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.

Trump Administration Promises Relief to Patients

By Pat Anson, Editor

A spokesman for the Trump administration pledged this week that the Department of Health and Human Services (HHS) would provide relief to patients who are "being harmed by the status quo.”

Matt Lloyd, a former top aide to Vice President Mike Pence, recently assumed the job of chief spokesman for HHS, the federal department that oversees the Food and Drug Administration, the Centers for Disease Control and Prevention, and the Centers for Medicare and Medicaid Services (CMS).

Lloyd made his comment in an unusual statement emailed to reporters after CMS released a report Friday that showed the number of Americans who signed up for insurance during Obamacare’s annual enrollment period had fallen to 9.2 million. That’s down from 9.6 million the year before.  

“Obamacare has failed the American people, with one broken promise after another. As noted in the report today from CMS, premiums in the ACA marketplace have increased 25 percent while the number of insurers has declined 28 percent over the past year,” Lloyd said.

MATT LLOYD

“We look forward to providing relief to those who are being harmed by the status quo and pursuing patient-centered solutions that will work for the American people.”  

Ironically, Lloyd made his statement two days after CMS invited public comment on the agency’s plans to have Medicare adopt the CDC’s opioid prescribing guidelines – a move that could affect thousands of patients who use opioids for pain relief. The CDC guidelines are voluntary and only intended for primary care physicians, but CMS wants to apply them to all doctors who prescribe opioids for non-cancer pain. A strict daily limit on opioids would also be set at 90 mg of a morphine equivalent dose.

Doctors and patients who don’t follow the proposed CMS policy could face punitive action, such as being dropped from Medicare coverage and insurance networks. CMS has estimated that over 15,000 Medicare beneficiaries who receive high doses of opioids for pain relief could be impacted  

CMS contracts with dozens of private insurance companies to provide health coverage to about 54 million Americans through Medicare.

The agency’s “Opioid Misuse Strategy” was developed during the final months of the Obama administration, but could be quickly adopted by the new administration.  CMS is only accepting public comments on its proposals until March 3 and plans to publish the final rules by Monday, April 3, 2017.

Comments on the CMS rule change should be mailed to:  AdvanceNotice2018@cms.hhs.gov.

Comments can be emailed to Matt Lloyd at: Matt.Lloyd@hhs.gov.

Medicare Planning to Adopt CDC Opioid Guidelines

By Pat Anson, Editor

The Centers for Medicare and Medicaid Services (CMS) has announced plans to fully implement the opioid prescribing guidelines released by the Centers for Disease Control and Prevention, which recommend that doctors not prescribe opioid medication for chronic non-cancer pain.

CMS is taking the CDC’s voluntary guidelines one step further, however, by mandating them as official Medicare policy and taking punitive action against doctors and patients who don’t follow them.

“When CDC released its guideline, I predicted that policymakers and payers would quickly move to convert CDC's voluntary recommendations into mandatory regulations, and my prediction appears to be coming true, both with CMS and with private payers,” said Bob Twillman, PhD, Executive Director of the Academy of Integrative Pain Management.

As Pain News Network has reported, CMS is adopting a “Big Brother” approach to fighting opioid abuse by developing a strategy that will encourage pharmacists to report doctors who may be overprescribing opioids and patients who may be abusing them. Information about these “potential opioid overutilizers” would be shared with insurance companies, which would be empowered to “prevent opioid overuse at point of sale at the pharmacy.”

CMS contracts with dozens of private insurance companies – known as sponsors -- to provide health insurance to about 54 million Americans through Medicare and nearly 70 million in Medicaid.

“To address the opioid epidemic, CMS has implemented a medication safety approach by which sponsors are expected to reduce beneficiary overutilization of opioids and maintain access to needed medications,” the agency said in a statement.

Saying it wanted to “better align” its policies with the CDC guidelines, CMS is proposing a daily ceiling on prescribed opioids at 90 mg morphine equivalent dose (MED). Any dosage above that level would be considered excessive. Patients who receive opioids from more than 3 prescribers and more than 3 pharmacies during a 6 month period would also be red-flagged.

Insurers would be expected to police pharmacies, doctors and patients who do not follow CMS policies, potentially dropping them from Medicare coverage and their insurance networks.

“Under the Part D opioid overutilization policy, sponsors are expected to implement appropriate plan-level claim controls at POS (point of sale) for opioids, use improved retrospective drug utilization review to identify beneficiaries at high risk for an adverse event due to opioids, and perform case management with the identified beneficiaries’ prescribers followed by beneficiary-specific POS edits to prevent Part D coverage of opioid overutilization,” CMS said.

Such a policy change would have a sweeping impact throughout the U.S. healthcare system because so many insurers and patients are involved. The Veterans Administration is the only other federal agency to adopt the CDC guidelines – and many veterans have complained that they are no longer able to obtain adequate pain relief at VA facilities.

Critics of the CMS strategy say it is even more draconian than the CDC guidelines, which are intended only for primary care physicians.

“CDC's ‘soft limit’ of 90 MED in treating chronic pain was a recommendation aimed at treatment of some people with chronic pain by primary care specialists. CDC stated that all of its recommendations were voluntary, and in this case, further provided prescribers with the option to use a higher dose if indicated by a careful risk/benefit analysis,” Twillman said in an email to PNN.

“In light of these limitations, it seems inappropriate for CMS to ask Part D providers to institute opioid dosing limits for people with pain who don't have cancer or are receiving hospice care, and for all prescribers, both primary care and specialists. 

Strategy Developed by Insurance Industry

The agency’s proposed “Opioid Misuse Strategy” was released publicly in early January.  It closely follows a 62-page “white paper” prepared by the Healthcare Fraud Prevention Partnership (HFPP), a coalition of private insurers, law enforcement agencies, and federal and state regulators formed in 2013 to combat healthcare fraud. 

The white paper, however, goes far beyond fraud prevention by recommending policies that will determine how a patient is treated by their doctor, including what medications should be prescribed. 

The number of Medicare patients who “overutilize” opioids is relatively small – just 15,651 beneficiaries in 2015 – which represents just 0.13% of Part D opioid users.

CMS is seeking public comment on the proposal in its 2018 Advance Notice and Draft Call Letter, which outlines a number of other changes the agency is making to its Medicare Advantage and Part D prescription drug programs. Comments will be accepted through March 3rd, with final versions published on April 3, 2017.

Comments can be emailed to: AdvanceNotice2018@cms.hhs.gov. 

Insurers Behind Medicare’s ‘Big Brother’ Opioid Policy

By Pat Anson, Editor

The insurance industry appears to have played a major role in the development of a new strategy by the federal government to combat the abuse of opioid pain medication.

As Pain News Network has reported, the plan calls on pharmacists to report suspicious activity by doctors who prescribe opioids to Medicare and Medicaid patients (see “Medicare Takes ‘Big Brother’ Approach to Opioid Abuse”). Individual profiles of patients, their behavior, and opioid use would also be created and shared among insurance providers.

The plan was outlined earlier this month by the Centers for Medicare & Medicaid Services (CMS) in the agency’s proposed “Opioid Misuse Strategy.” 

The CMS plan closely follows a 62-page “white paper” prepared by the Healthcare Fraud Prevention Partnership (HFPP), a coalition of private insurers, law enforcement agencies, and federal and state regulators formed in 2013 to combat healthcare fraud. 

The white paper, however, goes far beyond fraud prevention by recommending policies that will determine how a patient is treated by their doctor, including what medications should be prescribed.  It states that all physicians should follow the opioid prescribing guidelines released by the Centers for Disease Control and Prevention, even though the guidelines are voluntary and explicitly state they are not intended for all prescribers.

The white paper was drafted largely by insurance companies – called “Partner Champions” -- including Aetna, Anthem, Blue Cross Blue Shield, Cigna, Highmark, Humana, Kaiser Permanente and the Centene Corporation.

“These HFPP Partner Champions have committed themselves to the creation of an HFPP White Paper that describes the best practices for serious consideration by all healthcare payers and other relevant stakeholders to effectively address and minimize the harms of opioids,”  the white paper states.

“Through coordinated action, payers, including members of the HFPP, have the opportunity to dramatically influence and reduce opioid misuse in the U.S. Simple actions performed systematically across a large group of stakeholders can considerably decrease the toll of prescription opioid misuse and OUD (opioid use disorder) in the U.S.”

Physicians and Patients Left Out

No other stakeholders in healthcare, such as physicians, pharmacists, hospitals or patients, were involved in a “special session” of the HFPP last October that led to the drafting of the white paper.

“It’s concerning that CMS appears to have developed a policy proposal regarding opioid prescribing solely on the basis of advice from a group dominated by the insurance industry, without asking for input from affected healthcare professional groups,” said Bob Twillman, PhD, Executive Director of the Academy of Integrative Pain Management, an organization of physicians who specialize in pain care.

“We have to be mindful of the vested interests of insurance companies in this issue. Some advocates have argued that pharmaceutical manufacturers have wielded outsized influence in previous policy decisions, but there has been precious little focus on the influence of payers, which seems obvious in this case.”

CMS contracts with dozens of private insurance companies to provide health coverage to about 54 million Americans through Medicare and nearly 70 million in state-run Medicaid programs.

“Who exactly are the individuals who put this information together for CMS… and what is their true aim?” asks Ingrid Hollis, the mother of a chronic pain patient. “It looks to me like collusion between insurance companies and federal agencies to cut costs.

“Senior citizens and those disabled with progressive painful diseases or injuries deserve better treatment than this. To single this community out for draconian policies based on what looks like purely profit motives in the name of ‘harm reduction’ is inhumane. Who is truly being harmed here?”

“When they describe insurance companies involved in their efforts as ‘Champions,’ it calls to mind comic book and movie heroes like Superman.  Superman was noble, his motives pure.  I don't think of profit-conscious insurers as being noble or pure in motive,” said Anne Fuqua, a disabled nurse, pain patient and patient advocate. 

“Involving insurance companies in setting policies that directly or indirectly impact prescribing and/or reimbursement presents a conflict of interest.”

Stewards, Stockers and Demanders

Under the proposed CMS policy, information about doctors and patients who’ve been red flagged by pharmacists for suspicious prescribing would be shared through a CMS database with all insurers. The companies would then be empowered to “investigate provider and beneficiary behaviors that may be indicative of fraud or abuse.” Violators could be dropped from insurance networks or lose their coverage.    

The HFPP white paper goes further, recommending that insurers develop profiles of each patient and classify them in one of three groups based on their behavior:

1. “Stewards” (patients who follow guidelines)
2. “Stockers” (patients who stockpile unused medications)
3. “Demanders” (patients who ask for medication)

“Segmenting patients by intentions/behaviors with regards to opioid prescriptions could help payers better target messages and disseminate tailored communications that are most salient to the recipient,” the white paper states.

“For example, stewards may be those who are more likely to adhere to the CDC guideline and seek non-pharmacologic or non-opioid pharmacologic therapies for chronic pain and stockers may be those who are likely to ask for an opioid prescription/have received an opioid prescription for chronic pain in the past.”

A data analysis of patients and doctors, according to the white paper, could also be used by insurers to develop computer models to identify “problematic actors and schemes” and “deny payments for prescriptions that do not conform to general prescribing practices.”

“The HFPP strongly encour­ages collaborative efforts to develop and widely disseminate effective strategies to identify: patients at risk of opioid misuse or OUD, providers whose opioid prescribing patterns fail to comply with quality indicators (such as the CDC Guideline for Prescribing Opioids for Chronic Pain), and methods that are particularly ef­fective at preventing or treating OUD,” the white paper states.

But critics say the profiling of patients and doctors, as well as the sharing of data from prescription drug monitoring programs (PDMPs), amounts to an invasion of privacy.

“PDMP data contains some of the most sensitive health information that is produced.  When PDMPs were introduced, confidentiality protections were stressed and prescribers and pharmacists could review the information,” says Anne Fuqua.

“Now, CMS is discussing their plan to provide open access to insurers participating in their database.  They flip between arguments that this will help insurers make sure people get needed treatments for addiction and fraud detection.  It's clear that detection of fraud and conserving on drug costs is the primary focus.”

Non-Opioid Treatments Encouraged

Like the CDC guidelines, the white paper discourages the use of opioid pain medication, and recommends that over-the-counter pain relievers such as aspirin, acetaminophen and ibuprofen be used as an alternatives, as well as “non-pharmacological” treatments like cognitive behavioral therapy and chiropractic care. Addiction treatment drugs such as buprenorphine and methadone are strongly recommended for anyone showing signs of opioid use disorder.

“Clinicians should consider opioid therapy only if expected benefits for both pain and function are anticipated to outweigh risks to the patient. If opioids are used, they should be combined with non-pharmacologic therapy and non-opioid pharmacologic therapy,” the paper states.

Critics say the recommendations – and threats of sanctions against those who don’t follow them -- could interfere with the doctor-patient relationship.

"Proposals, like CMS' Opioid Misuse Strategy, aimed at combatting the prescription drug abuse crisis, while important, must be careful to not leave patients with a legitimate medical need without access to the treatments they and their doctors have determined are the best course of care,” the Alliance for Patient Access, a national network of physicians, said in a statement to PNN.

“Patient access can be impeded when physicians and patients feel threatened that they are being watched, may be reported, or their personal information shared by pharmacists and insurers. When that happens patients suffer and the physician-patient relationship, one based on trust, is strained.” 

“It should not be a surprise that insurance companies have been aggressively opposing the use of branded opioids. Their fiduciary responsibility is to their shareholders, not to patients,” said Lynn Webster, MD, past president of the American Academy of Pain Medicine. “Decisions by insurance companies are causing many patients to suffer. This is not right.”

“Patients and doctors don’t want insurance companies and other parties determining what is best for them.  Doctors have a medical degree, the experience, the knowledge and treatment plans are determined by the medical condition they are treating,” says Ingrid Hollis.

“They act in the best interest of the patient, and have pledged the Hippocratic Oath of ‘Do no harm.’ Can the same be said of the bean counters in the insurance industry? Insurance is interested in cost cutting and maximizing profits.  Doctors are trying to save lives.”

CMS has not said when it plans to implement its Opioid Misuse Strategy or if public hearings would ever be held on them. The agency has only said that in coming weeks it would release “statements reflecting the agency’s Medicare and Medicaid goals.”

The HFPP white paper was released publicly for the first time Tuesday on the CMS website, without any explanation of its broader meaning or impact on Medicare and Medicaid policies.

An HFPP infographic urging people "to fight healthcare fraud, waste and abuse" was also released on the government-run website, without any indication that it was largely developed by the insurance industry.

Pain Community Reacts to ‘Big Brother’ Medicare Policy

By Pat Anson, Editor

Here we go again.

That’s seems to be the reaction from many in the pain community to plans by the federal government to have pharmacists report suspicious activity by doctors who prescribe opioids to Medicare and Medicaid patients. (See “Medicare Takes Big Brother Approach to Opioid Abuse”)

The Centers for Medicare & Medicaid Services (CMS) says its new strategy to fight opioid abuse is aimed at “incentivizing prescribing behavior” by having pharmacists identify and report doctors who may be overprescribing opioids and patients who may be abusing them. 

“It is a terrible idea to pit pharmacist against physicians. It is an unbelievably perverse way to solve a serious healthcare problem that requires trust and collaboration among all the stakeholders,” said Lynn Webster, MD, past president of the American Academy of Pain Medicine. “Many, many people with pain and addiction are going to be harmed by this decision.”

“This will only serve to further increase stigma and increase distrust between patients, their prescribers, and pharmacists,” says Anne Fuqua, a former nurse, chronic pain sufferer and patient advocate.

“Just the words ‘incentivized prescribing’ makes me shudder.  It may well help root out a limited number of substance abusers and decrease pharmacy claims for Medicare Part D and Medicaid, but this is neither an effective manner to intervene when substance abuse does exist nor an ethical way to decrease prescription drug benefit claims.”

CMS contracts with dozens of private insurance companies to provide health coverage to about 54 million Americans through Medicare and nearly 70 million in state-run Medicaid programs. Under the new policy, information about doctors and patients who’ve been red flagged by pharmacists would be shared through a database with all insurers. The companies would be empowered to “investigate provider and beneficiary behaviors that may be indicative of fraud or abuse.” Violators could be dropped from insurance networks or lose their coverage.    

“A policy like this, that encourages pharmacists to report the prescriber or patient to the insurer for investigation, is dubious enough.  It's even more serious that the allegations would be entered in a database whether or not they are proven,” said Fuqua. “This would be like your doctor saying they think it's possible a patient is misusing medication and then emailing this to all the doctors in your state.  Every element of this reeks of big brother and directly contradicts treating addiction as a health issue.”

“It appears that CMS is dictating that pharmacists perform activities that are both outside of their training and the legal authority granted to them under the state's practice act,” said Steve Ariens, a retired pharmacist and patient advocate. “Pharmacists don't have access to the patient's entire medical records. They are being told by CMS to both diagnose and prescribe what is right for a patient.”

“Many of the pharmacists I know are already overworked with other regulations to the point of PDMP’s not being updated in a timely manner. I know of patients who have been affected by this personally,” said Barby Ingle, president of the International Pain Foundation and a PNN columnist.   

“What a pharmacist believes about a medication’s appropriateness should not come into play when they are not trained on the medical aspects of chronic conditions. Pharmacists know about medication, but not in-depth information on diseases we are living with and therefore should not be making the call on what they deem suspicious on behalf of a prescriber.”

Medicare Policy Based on CDC Guidelines

CMS is basing many of its policy decisions on opioid prescribing guidelines released last year by the Centers for Disease Control and Prevention. The guidelines, which discourage doctors from prescribing opioids for chronic pain, are voluntary and meant only for primary care physicians. But they are being widely adopted by insurers and doctors throughout the country as a “standard of care,” even though the scientific evidence supporting many of the guidelines is weak.

CMS seems unconcerned by that lack of evidence.

“Where sufficient evidence was not available, the CDC guidelines are based on expert opinion, as noted by the CDC,” the agency said in a 30-page briefing paper on its Opioid Misuse Strategy.

“The guidelines were formed by consensus of mostly people with agendas, biased against opioids, and totally insensitive to the needs of people in pain. The dose limits suggested by the CDC guidelines are arbitrary, not evidence based,” said Dr. Webster. “

“Let's be clear about the CDC guidelines.  A major reason the guidelines were developed was to reduce cost of drugs for payers.  If Medicare and Medicaid patients have an increasing incidence of opioid use disorder it is because these people do not have any alternative treatments for their pain other than an opioid. 

“If CMS is going to endorse the guidelines that have little to no science basis, then they should mandate all of the alternative therapies to opioids have unlimited coverage and that payers be mandated to provide adequate coverage for the underlying reasons that lead to opioid use and mental health disorders.  This would more likely reduce the incidence of an opioid use disorder.”

CMS is not requiring insurers to cover alternative pain therapies, such as massage and acupuncture, but says it is a prioritizing efforts to develop more evidence to support their use.

Public Not Informed

CMS convened a “cross-agency working group” to develop its opioid misuse strategy, and says it is “working closely” with other federal agencies such as the CDC, Food and Drug Administration, National Institutes of Health, and the White House Office of National Drug Control Policy. Members of the working group were not identified.

“CMS sought representatives from every component of the agency to ensure a broad range of expertise and perspectives. This diverse group assessed the benefits, limitations, and improvement opportunities within CMS’s current policies and programs. The group then defined desired outcomes from the perspective of CMS’s unique role as a leading payer of health care and identified key actions to achieve those outcomes,” the agency said in a statement on its website.

But CMS never held a public hearing or sought public comment prior to the strategy’s release last week. Several medical organizations and patient advocacy groups contacted by Pain News Network were unaware the policies were even being developed. 

“I was not even aware that these new CMS policies were being created and as a patient on Medicare, I think that we should have been notified at minimum,” said Barby Ingle. “Our opinion as patients in the program should have been a part of the voice of something that will affect proper and timely access to care.”

“Society would never tolerate any other patient group being treated in this manner,” said Anne Fuqua. “It's no accident that this provision has been given so little attention.”

On its website, CMS says it now welcomes “input from clinicians, patients, consumers, caregivers, manufacturers, researchers and others.” But it never makes clear how interested parties can comment or participate, such as a notice or public comment period published in the Federal Register.

The secretive actions of the agency – so far – are similar to those used by the CDC in developing its opioid prescribing guidelines. For several months, the CDC refused to identify members of a “core expert group” that helped draft the guidelines, which were released in September 2015 to a small and mostly selected online audience.

Initially, the public was given only 48 hours to comment on the CDC guidelines -- a decision that was reversed after a public outcry and threats of a lawsuit. Over 4,300 public comments were later received online, most of them in opposition to the guidelines, which were released virtually unchanged in March 2016.

CMS has not responded to repeated requests for an interview about its opioid misuse policies. It is not clear when the policies will be initiated, who was involved in drafting them, or where the idea came from.

CMS caved into political pressure last year when it agreed to drop pain related questions from patient satisfaction surveys. Politicians, hospitals, the American Medical Association, and other health organizations all claimed the questions encouraged the overprescribing of opioids. CMS officials said there was no evidence that was true, but agreed to eliminate the questions in 2017 patient surveys. The agency is still working on a future set of questions to replace them.

Medicare Takes 'Big Brother' Approach to Opioid Abuse

By Pat Anson, Editor

A new strategy being developed by Medicare to combat the abuse of opioid pain medication will encourage pharmacists to report physicians who may be prescribing opioids inappropriately. Patients that a pharmacist believes are abusing opioids could also be referred for investigation.

The strategy, which has yet to be finalized, was outlined by the Centers for Medicare & Medicaid Services (CMS) last week in a 30-page report on the agency’s “Opioid Misuse Strategy.”  It has not been widely publicized by CMS or reported in the news media.

“Many Medicare and Medicaid beneficiaries and their families have experienced opioid use disorder, commonly referred to as addiction,” the agency says in the report’s executive summary.

“Given the growing body of evidence on the risks of misuse… CMS is outlining our agency’s strategy and the array of actions underway to address the national opioid misuse epidemic.”

One strategy CMS will explore is “incentivizing prescribing behavior” by encouraging physicians and pharmacists to consult with prescription drug monitoring programs (PDMPs) to review each patient’s prescription drug history. The use of PDMPs is fairly widespread already, but CMS would take it a step further by encouraging pharmacists to report suspicious activity by prescribers and patients.

“Pharmacies would be able to identify prescribers with potentially illicit prescribing practices or beneficiaries (patients) who may be overusing opioids. This information can be referred to health plans to investigate provider and beneficiary behaviors that may be indicative of fraud or abuse.”

Investigations of abuse or inappropriate prescribing would be shared with insurers enrolled in the giant Medicare/Medicaid system, even if the allegations are never proven. CMS contracts with dozens of private insurance companies to provide health insurance to about 54 million Americans through Medicare and nearly 70 million in Medicaid.

“Part D plans can use CMS’s information sharing platform to identify leads for their own internal investigations and can report actions they have taken. For example, if one plan sponsor suspects a provider of inappropriate prescribing behavior, it can alert other plans to that possibility so that those plans can conduct their own evaluations and take coordinated action if warranted.

“The results of these projects are provided to plan sponsors so that additional actions can be taken, including initiating new investigations, conducting audits, or terminating physicians and pharmacies from their network.”

“It looks like ‘Big Brother’ is going to watch everyone,” says Rick Martin, a retired Las Vegas pharmacist who suffers from chronic back pain.

“Pharmacists are going to be even more paranoid than they already are," Martin wrote in an email. “Retail pharmacists don't have time for this. They aren't the police. Nevada has a PDMP. It already shows a significant decrease in prescribing patterns over the last several years, so it is working.  With the CMS, just who decides what are appropriate quantities and proper prescribing habits?”

CMS Using CDC’s Prescribing Guidelines

In developing its strategy, CMS is relying heavily on prescribing guidelines released in 2016 by the Centers for Disease Control and Prevention, which discourage doctors from prescribing opioids for chronic pain. CMS says it will use the “evidence-based guidelines” to determine what constitutes inappropriate prescribing. The guidelines include a recommendation that opioids be limited to no more than 90 mg of morphine equivalent milligrams a day, a dose that many patients in severe chronic pain consider inadequate. 

The CDC maintains the guidelines are “voluntary” and intended only for primary care physicians. However, under the CMS strategy, the guidelines would apply to all prescribers, except those treating cancer or patients in palliative care.

“I just hate to see something that CDC itself said was voluntary, was a recommendation, and really isn’t all that specific if you really read it, get turned into something that creates bright red lines. And if you step across the line, you’re going to get yourself in trouble. I don’t think that’s right,” said Bob Twillman, PhD, Executive Director of the Academy of Integrative Pain Management, the nation's largest pain management organization.

CMS says the additional scrutiny of doctors and patients is needed because “the Medicare population has among the highest and fastest-growing rates of diagnosed opioid use disorder,” which the agency estimates at 6 out of every 1,000 beneficiaries. Addiction rates are higher among Medicaid beneficiaries, at 8.7 patients for every 1,000, a figure 10 times higher than patients covered by private insurance plans.

“Because there is no systematic policy of screening for opioid use disorder and patients are unlikely to volunteer that they are misusing their medication or are using opioids like heroin because of discrimination and stigma, these rates are likely underestimates,” CMS says.

Rick Martin believes the Medicare policies will make physicians even less likely to prescribe opioids and pharmacists less likely to fill legitimate prescriptions.

“Pharmacists, like the docs, are just plain scared. If they don't know you, many are reluctant to fill,” said Martin, who is enrolled in Medicare's Part D prescription drug plan.

“One pharmacy I went to refused to fill my bona fide legitimate prescription because it exceeded an arbitrary amount. The manager didn't want any extra scrutiny from DEA, the home office, the PDMP, the board of pharmacy, or the (drug) wholesaler. Even though I was in the system for over 2 years and had previously had even higher amounts filled.

“One of the pain docs I am working with told me he has gotten numerous letters from Humana and one other (insurer) because he is in the upper 1% of dispensing opioids. Well, duh!  He is an exclusive pain management doctor. They didn't compare him with other pain doctors, just ALL doctors. Stupid. What will the CMS do on top of what goes on already?”

Bob Twillman worries the CMS strategy will create distrust between physicians and pharmacists.

“We’ve been trying to make efforts over the last few years to get pharmacists and physicians to work more closely together. I’m concerned this could increase suspicion between the two and be counter to that effort,” said Twillman. “Getting prescribers and pharmacists to work together is an important thing in enhancing patient safety and if we do something like this and short circuit that effort we’re doing more harm than we are good.”

CMS did not say when it planned to implement its Opioid Misuse Strategy or if public hearings would ever be held on them. The agency only said in coming weeks it would release “statements reflecting the agency’s Medicare and Medicaid goals.”

Also unclear is why CMS and the Department of Health and Human Services would take a major step affecting the healthcare of tens of millions of patients and their doctors in the final days of the Obama administration.

“The fact that this is coming out a couple of weeks before the new administration comes in does make it a little bit odd. It makes me wonder how many legs it has or whether it will carry over into the next administration,” said Twillman.